The online version incorporates links (in blue) to other pertinent procedures. medical diagnostic
. OPTEK provides sensor technologies such as optical (IR. Requests for changes should be submitted to the Management Representative. The online version of this quality manual is available to all employees via computers. The quality management system developed by this manual was based on & demonstrates throughout its wording good quality principles such as leadership. process maps. Representative 3-18-09 Date Bob Taber President / C. Avenue Rio Bravo #1551 Park Industrial Rio Bravo. the continual improvement of the system and the prevention of nonconformity. 3-23-09 Date
Overview of TT electronics / OPTEK TT electronics / OPTEK Technology. visible. continual improvement. OPTEK sensors are found in office equipment. process focus. Cd. and that they are kept informed of any changes and updates. is headquartered at 1645 Wallace Drive.: 6 of 46 Revision: D Issued: 2010/April/9
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About this Manual This manual was developed for a quality management system aimed primarily at achieving customer satisfaction by meeting customer requirements through the application of the system.Page No. military & Hi-Rel applications. UV & VCSEL). manufacturing. Rodney Bailey Mgmt. involvement of the employees. 2004 Approvals:
J. hereafter called OPTEK. management by a system of processes and ultimately decisions that are based on good sound data. Carrollton. mutually beneficial supplier relationships. Juarez. and sale of electronic sensors.5G). and documents making it use easier than a printed version.E. The Management Representative maintains this manual for the Quality Management System and for Optek employees’ use. The online version is to be considered the most current and takes precedence over any printed copy. Updates of the manual are issued as required. customer focus. Chihuahua Mexico 32700. Texas 75006 with manufacturing facilities at Optron de Mexico.
Effective date of this quality manual: May 3. It is the responsibility of the Department Heads to ensure that employees are familiar with the manual’s content related to their work and responsibilities. industrial applications. magnetic (Hall-effect) and fiber optic (LED & VCSEL to 2. encoders. OPTEK’s business activities are the design.O.

requirements ISO 9004: 2000. Sensors can be standard product or custom made to customer’s specification. Carrollton. the terms and definitions for the automotive industry specified in clause 3. Quality Management Systems . Its purpose is: • for internal use. the manufacture of custom made piece parts and final products as well as the construction of dies and fixtures at either OPTEK’s location at 1645 Wallace Drive. Quality Management Systems . and demonstrates compliance with customer and regulatory requirements.1 of ISO/TS 16949 are applied. to make the employees familiar with the method of compliance with ISO/TS 16949 requirements. Applicable Standards The content and application of this quality manual makes reference to the following publications and documents: • • • • ISO/TS 16949:2009.fundamentals and vocabulary ISO 9001: 2008.
. to inform OPTEK’s customers and other interested external partners about OPTEK’s Quality Policy.
This quality manual describes the Quality Management System of OPTEK. Texas 75006 or Optron de Mexico.Page No. to communicate to employees the company’s Quality Policy and quality objectives.particular requirements for the application of ISO 9001:2008 for automotive production. Quality Management Systems . Quality Management Systems . automotive engine and door controls and ignition security and fiber optic data communication applications. The scope of the Quality Management System covers the design and manufacturing of sensor systems. to facilitate the implementation and maintenance of the Quality Management System and to ensure its continuity and required updates during changing circumstances. ISO 9000: 2000. to provide effective communication and control of quality related activities and a documented base for quality system audits. OPTEK’s implemented Quality Management System. and measures of compliance with the requirements of ISO/TS 16949. • for external use.: 7 of 46 Revision: D Issued: 2010/April/9
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equipment. is focused on the enhancement of customer satisfaction through continual improvement of processes and products.guidelines for performance improvement
For this quality manual. OPTEK’s Quality Management System meets all requirements of ISO/TS 16949:2009 and no exclusions are applied. Juarez manufacturing site. Scope This Quality Management System described hereafter complies with all the requirements of ISO/TS 16949 Revision 2009.

Business Unit Managers. It is the responsibility of the Management Representative and Department Heads to ensure that the activities/processes included in the scope of this Quality Management System are identified and are performed in compliance with ISO/TS 16949. operating procedures. flow charts.: 8 of 46 Revision: D Issued: 2010/April/9
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The quality manual includes the scope of the Quality Management System with no exclusions from the requirements of ISO/TS 16949 and their justification. Sales and Customer Service and Quality Management System Administration are in compliance with ISO/TS 16949. etc. Engineering and Administration. c) It is the responsibility of the Management Representative and Department Heads to apply the necessary techniques and criteria in order to verify that established processes/activities and their implemented controls are effective. b) It is the responsibility of the Management Representative and Department Heads to ensure that the sequence and interaction of processes or activities of this Quality Management System are determined in a suitable manner. Manufacturing. Manufacturing. 1 Management Processes 1. documented as required. d) It is the responsibility of the President/CEO. Warehouse. managed and maintained according to the requirements of ISO/TS 16949 • to continually improve the effectiveness of the Quality Management System 1. Management Representative and the Department Heads to ensure that the necessary human and material resources. as well as the necessary information. makes reference to applicable operating procedures and other pertinent documents.
. quality plans. are available to ensure the effective operation and control of the processes of the Quality Management System.Page No. utilizing tools such as process maps. Purchasing. Reporting to the President/CEO and his Executive Staff are the department managers of Quality Assurance. Process Map #001 is a description of the Quality Management System interaction of processes Management Structure The management of OPTEK consists of the President/CEO. implemented.1 QMS General Requirements a) Operational and administrative activities affecting quality of the departments Engineering.1 Quality Management System Implementation & Maintenance It is the responsibility of the Management Representative • to ensure that the Quality Management System of OPTEK is established. Quality Assurance.1. Toolroom.

master lists. 8. as well as records necessary to meet other internal and external requirements.3 Control of Nonconforming Product. 8. as well as the continual improvement of these processes/activities. the Management Representative and Department Heads ensure that action is taken to obtain expected results of processes/activities.4 Control of Records. operating instructions. which affect product conformity.2 Internal Audit. In addition. 8. Quality Assurance via Supplier Quality establishes and implements the necessary controls for approval processes to ensure conformance to specified requirements. f) As required. g) QMS Documentation requirements As a minimum. quality plans. It is the responsibility of the Management Representative to ensure the availability of corporate documents of the Quality Management System and documents required by ISO/TS 16949.: 9 of 46 Revision: D Issued: 2010/April/9
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e) It is the responsibility of the Management Representative and Department Heads to ensure that the processes / activities which are part of the Quality Management System are monitored.2. These implemented controls however do not absolve OPTEK from the responsibility of supplying products that meet customer requirements. The document structure of OPTEK’s Quality Management System consists of two levels: 1) The Quality Manual. 4. measured and analyzed regarding their achievement of planned results.5. control plans and other documents needed by OPTEK for the effective and efficient operation of the Quality Management System.3 Control of Documents. forms.2. operation and control of processes of the Quality Management System • records required by ISO/TS 16949 and by OPTEK to ensure appropriate control and evidence of compliance with requirements. describing the Quality Management System of OPTEK and its compliance with ISO/TS 16949 2) Operating procedures.Page No.3 Preventive Action • other documents needed by OPTEK for the effective planning. are outsourced.2 Corrective Action and 8.5. work instructions. the documentation of OPTEK’s Quality Management System includes • a Quality Policy and objectives • this quality manual • required documented procedures or maps for ISO/TS 16949 clauses: 4.2. records are created as required by ISO/TS 16949.2. In the event that processes.2.2 Training.
. 6.

2 Management Commitment The management of OPTEK is committed to the development. including product realization processes and support processes. In order to provide this evidence. yearly management reviews are conducted to verify the effectiveness. MF09) • resources for the implementation and maintenance of the Quality Management System and its processes are provided in a timely manner • at a minimum. 1.1.4). operating instructions and any other documents related to their departments.1 & 1. Bob Taber President / CEO
March 2010
. control and functioning of the Quality Management System and its processes.Page No.1. 1. the President/CEO ensures that: • a corporate Quality Policy is established • quality objectives are established by selected departments based on the company business plan • the importance of meeting customer requirements and statutory and regulatory requirements is part of the training of each employee (QS02. that are necessary to ensure the effective implementation.1. OPTEK is committed to its Quality Management System.2. 1. which meets the needs of OPTEK and its customers. The effectiveness of these procedures is measured through customer satisfaction surveys. efficiency and proper functioning of the Quality Management System.1.: 10 of 46 Revision: D Issued: 2010/April/9
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It is the responsibility of the Department Heads to ensure the development and availability of documented procedures. Quality Objectives and will continually improve their effectiveness.3 Customer Focus The President/CEO ensures that procedures for determining and meeting customer requirements are established and implemented.
Corporate Quality Policy OPTEK is dedicated to delivering Reliable World Class competitive products on time to meet the requirements of our customers. which are part of Management Reviews (see 2. work instructions.4 Quality Policy The management of OPTEK has developed a Corporate Quality Policy. implementation and optimum functioning of the Quality Management System and the continual improvement of its effectiveness.

Updated charts are distributed to Department Heads and are available to employees on a need to know basis. for meeting internal requirements and customer requirements. implemented and approved. The Quality Policy is made known within the organization and understood and adhered to by employees. and provides a basis for the establishment and review of quality objectives. coordinate and plan the efficiency and effectiveness of the Quality Management System and the realization of established quality objectives of the departments. that changes to the Quality Management System are documented. showing the workflow of the department as well as evidence of compliance with the requirements of the quality system. the Management Representative calls for a meeting of the Department Heads with the purpose to review.Page No.
. Planning activities are documented and are consistent with other requirements of the Quality Management System. and that the Quality Management System is properly maintained during these changes.1 of ISO/TS 16949 are included in this planning process. quality plan. that changes resulting from planning activities are coordinated and implemented in a controlled manner. results from audits of the Quality Management System as well as permissible exclusions according to ISO/TS 16949 are considered.1. The Quality Policy includes OPTEK’s commitment for continual improvement. 1. Each Department Head develops and maintains a process map. flow chart. as well the coordination of improvement opportunities. etc for his/her department.1. The General Requirements of clause 4. It is the responsibility of the Management Representative to ensure that resulting organizational changes and their consequences are identified and defined. The output of these planning activities includes the identification of required resources. As appropriate.5 Quality Management System Planning In the first and the third quarter of the year. the Quality Policy is reviewed for its continuing suitability. 1.6 Responsibility and Authority It is the responsibility of the Management Representative to develop and maintain an organization chart of OPTEK. Note: the Quality Planning Team under the responsibility of the Manufacturing Department performs Quality planning for manufacturing process activities. During management reviews.: 11 of 46 Revision: D Issued: 2010/April/9
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It is the responsibility of OPTEK’s management to implement and maintain this Quality Policy. operating procedure.

defined.Page No. In yearly performance reviews.
. in the quality improvement process. Documents are updated as required. the Department Head can transfer the nonconformity to the Quality Planning Team for review and action. employees are made aware of the importance to meet customer requirements and expectations.1 Responsibility for quality It is the responsibility of personnel in Quality Assurance. It is the responsibility of the Department Heads to ensure that customer requirements and customer expectations. to inform the responsible Department Head of any nonconformity of products or processes. In the event of nonconformity in production. or when required. If necessary.1. The Department Head is responsible for the development and approval of the department’s procedures and work instructions. or personnel in Production and Warehouse. all personnel are responsible for product quality and have the authority to stop production in order to correct any quality problems. The Department Head is notified of any identified nonconformity or deficiency where the correction or prevention of such nonconformity or deficiency is out of the employee’s scope of responsibility.1. and are assessed and re-defined as necessary.6. together with other responsibilities of the function. In addition. It is the duty of each employee to inform the Department Head or the Management Representative when performed activities do not match the established procedures. documented and met. are reviewed and discussed between the Department Head and the employee.3 Individual responsibility All employees follow the policies and guidelines outlined in the quality manual and in established procedures. are identified. 1. It is ensured that an employee responsible for quality is present at all times during production.: 12 of 46 Revision: D Issued: 2010/April/9
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1. or when established procedures and work instructions are unclear or ambiguous. that the department’s personnel adheres to all applicable procedures and work instructions and participates.6. which relate to activities under the department’s responsibility. are defined in procedures and job descriptions. Corrective action is taken as appropriate. these responsibilities for quality. including action for the review and improvement of processes. The Department Heads ensure that the department staff understands and follows the applicable policies and guidelines outlined in the Quality Manual. 1. as appropriate.6.2 Departmental responsibility for quality The responsibility for quality in each department rests with the Department Head. Department Heads ensure that the responsibility of employees or functions whose activities affect quality.1.

where required .7. including quality objectives for other departments
. Responsibilities related to customer requirements include: Sales: • coordination of issues related to customer requirements • recommendations for corporate quality objectives. including quality objectives for other departments • quality planning activities • product design and development • communication with customers on technical issues • customer prototype support Manufacturing: • recommendations for corporate quality objectives.7 Management Representative The management of OPTEK appoints a Management Representative who. implementation and administration of the Quality Management System. has the defined authority and responsibility for • ensuring that a Quality Management System is established. Engineering and Manufacturing. including quality objectives for other departments • conveyance of temporary deviations to customers • analysis of feedback from customers regarding nonconformities • follow-up on corrective actions Engineering: • recommendations for corporate quality objectives. 1.1. and the direct responsibility of addressing customer requirements to the Department Heads of Sales.1. implemented and maintained in accordance with the requirements of the international standard ISO/TS 16949 • reporting on the performance of the Quality Management System to management for review and corrective action. with external customers and suppliers and other external partners and authorities • promoting the awareness of customer requirements and expectations throughout the company The Management Representative is responsible for the overall coordination.Page No. including needs for improvements • the proper coordination .of quality related issues and activities within the company.: 13 of 46 Revision: D Issued: 2010/April/9
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1. irrespective of other duties and responsibilities.1 Customer representative The management of OPTEK has assigned the inter-departmental coordination of customer requirements to the manager of the Sales Department.

shipping inspection The Sales Department is informed of corrective actions taken by the responsible department regarding the compliance with customer requirements. to the achievement of quality objectives and customer satisfaction Records of employees’ education. Also included are resource requirements for new projects and other quality related activities.1. 1.9. In the department’s budget are provisions for the employment and assignment of qualified and trained personnel.1. for meeting customer requirements and achieving customer satisfaction. Related expenses are included in the company’s financial budget.Page No. determined and documented in job descriptions. maintenance and continual improvement of the processes of the Quality Management System.8 Provision of Resources Management ensures that approved material and human resources.General It is the responsibility of the Department Heads to identify qualification requirements of functions or personnel assigned to defined activities that affect quality of product.1. Employees are made aware of the importance and the impact of their work in relation to product quality. The effectiveness of provided training or of related actions is evaluated. awareness and training Department Heads ensure that the qualification requirements (such as education. skills.9. training. experience) for each job are identified. 1. MF01) or other actions are taken in order to meet defined qualification requirements.2 Product design skills It is the responsibility of Engineering to ensure that personnel with responsibility of product design are qualified for the job and have the necessary skills and experience as specified in the applicable job description. skills and experience as appropriate. 1. Qualification requirements include education.9 Human resources .: 14 of 46 Revision: D Issued: 2010/April/9
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special training requirements for production and warehouse production planning issues related to customer supplied products (in coordination with Purchasing and/or
• • •
Supplier Quality Engineering) • delivery requirements . which have been identified by the Department Heads during budget planning and quality planning. are available in a timely manner. This refers to resources required for the implementation. training.
. Training is provided to employees (QS02. 1. experience and other qualifications are maintained.1.1 Competence.

inspection and test activities. The HR Representative (MF09) provides training for safety and the handling of hazardous materials. 1. advantages. Prior and during the planning process.3 Training The Management Representative establishes and maintains the documented procedure (QS02 Training) for identifying training needs and for providing required training to employees who are performing activities affecting product quality. Planning activities are consistent with other requirements of the Quality Management System.Page No. assigned to new or modified responsibilities affecting product quality. validation. 1. and criteria for product acceptance Records for providing evidence that manufacturing processes.1. monitoring. An alternative would be to post these articles on the company’s bulletin boards/electronic bulletin boards. the planning process covers provision of resources necessary. As appropriate.
. Promoting the awareness for quality and technology to all employees is part of this process. quality objectives and quality requirements for product related to the planning project are established by the quality planning team.9.5 Employee motivation and empowerment To promote innovation. the Management Representative publishes quarterly at least one article in the company’s bulletin regarding the importance.9. Personnel performing activities that can affect quality are informed of potential consequences to the customer in the event that defined requirements will not be met (QS02). manufacturing processes and documents. required verification.9. Performance reviews conducted by the Department Heads include and document the degree of employee’s awareness regarding the importance of their work and their contribution in achieving quality objectives.1. are trained on-the job.1. to motivate employees in accomplishing quality objectives and to participate in the continual improvement process.10 Planning of Product Realization The Engineering Department is responsible for the quality planning (EG01) of the production processes of new products and for changes of existing products. 1.1. The procedure includes training for the fulfillment of specific customer requirements. and manufactured product meet requirements are defined and specified.: 15 of 46 Revision: D Issued: 2010/April/9
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1. This applies only to on-site contracted personnel.4 Training on the job Department Heads ensure that personnel. challenges and past achievements of these activities.

1 Planning of product realization . 1. Review) At planned intervals. writes the minutes of the meeting. The review includes the evaluation of the need for changes to the Quality Management System. The Management Representative. achievement of quality objectives and customer satisfaction.10. the impact of changes is reviewed with the customer.2.10. approved by the customer.Supplemental Customer requirements and references to technical specifications are included in the quality plan.1. Department Heads and employees are invited to attend the meeting when issues of his/her area of responsibility are discussed. including changes to products/materials from suppliers.1 and 8. validated and approved by Engineering prior to use and implementation. ensures that the required data and documents are available for management review.1. prepares the agenda of upcoming meetings. As required. are assessed.4. Management is kept informed on the status of follow-up activities.1 of ISO/TS16949. as required. 1.1. and the cost of poor quality according to clauses 8.4 Change control Changes to production processes (EG01). with the input from management. If requested by the customer. 1. For proprietary designs.1 General .2.3 Confidentiality Confidentiality of information and data about customer-contracted products/projects is ensured (EG01).10. Records of management reviews are maintained. management and the Management Representative have a formal meeting to discuss and review (Process Method #002) the continuing effectiveness and adequacy of the Quality Management System. This review covers all clauses of the Quality Management System.Page No. informs results to the Department Heads and individuals concerned and follows-up on required actions resulting from these meetings.1.: 16 of 46 Revision: D Issued: 2010/April/9
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1.2 Acceptance criteria Acceptance criteria are defined in the planning process and. as well as the assessment of improvement opportunities based on the review and analysis of performance trends. Acceptance for attribute data sampling is zero defects (EG01). 1. the Quality Policy and quality objectives. 1.10.2 Management Review 1.1.1 Review Input As a minimum. the following inputs are to be considered for at least one meeting during the year:
. additional verification/identification requirements are met.5.Quality Management System Performance (Mgmt.

warranty repairs. design/development of products and processes) achievement of corporate quality objectives. incl.: 17 of 46 Revision: D Issued: 2010/April/9
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performance of production processes. and Quality Management System results of internal and external audits of the quality system. etc. and their involvement in the quality improvement process availability and effectiveness of internal and external information within the company. including performance trends status and effectiveness of corrective and preventive actions follow-up actions from previous management reviews planned changes that could affect the Quality Management System assessment of improvement opportunities and recommendations for improvements employees’ knowledge. rework.scrap. warranty repairs). at all levels human resources. returns. excessive freight charges. analysis of field-failures (returns. training and staffing requirements suitability of working environment availability of material resources effectiveness of quality planning (quality system. which includes: quality system audits conducted by the Registrar internal quality audits customer satisfaction surveys and other customer feedback regarding customer satisfaction customer complaints suppliers performance product and service quality and nonconformities direct and indirect costs and benefits of the quality system (relation cost . directives and procedures. product conformity. understanding and adherence to quality policies.Page No. audits of manufacturing processes statistical results of operational performance. including those specified in the business plan achievement of departmental quality objectives effectiveness of continual improvement activities of products. environment the impact or potential impact of changes that could affect the Quality Management System opportunities for improvement resulting from additions or changes
• • • • • •
• • • • • • • • • •
.benefit) cost of poor quality . their impact on quality. safety. processes. based on the analysis of collected data.

as appropriate . teamwork.10). These quality initiatives will be reviewed each year to ensure alignment with the business plan. Corporate quality initiatives Based on the corporate Quality Policy. Yearly quality objectives and measurements are established by Department Heads for their departments based on these Quality Initiatives.2 Review Output Results of the assessment and conclusions of management reviews include the following output: • effectiveness of corrective and/or preventive actions • the suitability and effectiveness of the Quality Management System • improvement of the effectiveness of the Quality Management System and its processes • improvement of product with focus on customer requirements • availability of human and material resources • suitability of the corporate Quality Policy • frequency of Management Reviews • required corrective and or preventive actions regarding items reviewed 1.2. include . • • • • • • Provide Exemplary Customer Satisfaction Be a leader in Advanced Technology Development Eliminate waste wherever it exists Be the industry benchmark for manufacturing capability Provide a work environment that promotes competency. empowerment and accountability Deliver exceptional financial performance over time
.objectives to meet product requirements (see 1. Management approves these departmental quality objectives. At least two quality objectives of the departments Manufacturing and Quality Assurance are related to the performance of product. Established quality objectives are consistent with the Quality Policy. the management of OPTEK has established the following corporate quality initiatives based on one premise – that of Exceeding the Customer’s Expectations.2.Page No. and are defined in such a way that their degree of achievement and results can be measured.1.1.2 Quality Objectives Each year. The completion and achievement of yearly quality objectives included in the business plan and departmental quality objectives are reviewed during management review regarding their level of achievement.: 18 of 46 Revision: D Issued: 2010/April/9
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1. management defines Corporate Quality Initiatives in the Business Plan.

Goal is to establish a base line measurement & reduce the average by 50% during the next 3 years
Specific measurements are tracked to demonstrate results with continual improvement
The end result of this process is to clearly tie the business plan into operational terms that have meaning to front line personnel at all levels within the organization.: 19 of 46 Revision: D Issued: 2010/April/9
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The translation from a Corporate Quality Initiative to a measurable index for demonstrating results and continual improvement is demonstrated in the following example: Corporate Business Plan
Corporate Quality Initiatives
Consistent compliance with customer requirements
Established by top management to set the direction for the business
Corporate Quality Objectives
Meet on time shipment requirements
Deployment strategies are Optek’s Quality Objectives
Sales Department will improve accuracy in the identification of customer & product info during the quote cycle – see Process Map #004
Objectives are deployed to the function or department with specific goals defined
Measurement: Track the number of errors in this information & graph.Page No. Our business objectives are our Quality Objectives
.

A summary of the achievement of the department’s quality objectives of the past year is documented by the applicable Department Head and submitted to the President/CEO. These quality objectives are in accordance with the corporate Quality Policy and are focused on the improvement of departmental processes/activities (see process maps). control charts.
. Survey results. The Management Representative monitors the effectiveness of these corrective or preventive actions.1 Identification of Statistical Tools During product quality planning (EG01). appropriate statistical tools are determined for each process and are included in the control plan. Engineering. This includes statistical methods for product development (variation analysis. the Management Representative develops and distributes quarterly statistics (QS04). 1. Toolroom and Quality Assurance establish quality objectives for his/her department. 1.2. 1. 1. customers’ business disruptions (QS06).: 20 of 46 Revision: D Issued: 2010/April/9
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Based on internal and external audit results and statistics issued by the Management Representative (QS04).3 Measurement Analysis & Improvement . dependability analysis.3.2. which include customer complaints and feedback. These statistics are analyzed by Department Heads and corrective and preventive action for the continual improvement of the Quality Management System is taken as appropriate. customer returns of nonconforming product (217-0027-001) and delivery performance (QS04) are analyzed and evaluated (QS05). Sales.Page No.3.). The departmental quality objectives for the coming year are submitted to the President/CEO for review and approval. Manufacturing. etc.2. for product verification (process capability. Departmental quality objectives Each year. and other processes.4 Customer Satisfaction Periodic customer satisfaction surveys (QS07) are conducted by management to verify if customer satisfaction has been achieved.). the conformity of the Quality Management System and its continual improvement.2. Training records are maintained (QS02). As required. variation analysis. Warehouse. the Department Heads of Administration.2 Knowledge of Basic Statistical Concepts Department Heads. management takes corrective or preventive action.General In order to demonstrate the conformity of manufactured product. with the assistance of the Management Representative ensure that personnel are trained in the use and application of basic statistical concepts defined by quality planning and used in their respective departments. these quality initiatives are reviewed during management reviews regarding their continuing suitability. etc.

The Management Representative controls and coordinates the implementation of required corrective or preventive actions.Page No. monitor results. A summary report is issued by the Management Representative.2.: 21 of 46 Revision: D Issued: 2010/April/9
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1. Engineering. and an information system for reporting of product information related to usage. and supplier performance. decision making and longer term planning. Ratings on supplier performance are issued by Purchasing and/or Quality Assurance (PU04). In addition. Purchasing and any other additional members deemed necessary. analyze and make final decisions on Corrective Action Requests (QSW01) and Quality Improvement Proposals (QSW03). suitability and opportunities for improvement of the processes of the Quality Management System. This includes the analysis of customer complaints (QS06) and customer returns (QA08). root causes are determined and required action is taken or recommended as appropriate. to coordinate and implement preventive actions and quality improvement projects. product quality. to make recommendations for preventive actions and quality improvements.
. Nonconformities and deficiencies are analyzed. trends in quality and operational performance are compared with progress toward objectives and lead to action to support: the development of priorities to resolve customer-related problems. and to provide a forum for any quality issue which requires a crossfunctional approach. Improvement It is the responsibility of the Management Representative to form and implement a Quality Planning Team for the handling of assigned activities related to the Quality Management System. Analysis results of statistics and actions are reported by the Department Heads to the Management Representative who monitors the progress and results of these actions. and by Department Heads regarding the performance and suitability of activities and processes under their responsibility. As required and/or decided by management. The purpose of the Quality Planning Team is to review.5 Analysis and Use of Data The Management Representative issues statistics regarding the performance of the Quality Management System (QS04) thru the analysis and use of data. to determine customer related trends and correlation for status review. providing information on: customer satisfaction or dissatisfaction. Members should be from Quality Assurance. selected Quality Improvement Proposals are referred to the Quality Planning Team for review regarding their feasibility and benefits. Manufacturing. characteristics and trends of processes and products including opportunities for preventive action. The statistics are analyzed by the Management Representative regarding the effectiveness. Sales.

1 Internal Communication Effective internal communication is essential for the proper functioning of the Quality Management System.6 Continual Improvement The planning. Any communication problem regarding the Quality Management System is reported to the Management Representative for corrective action.Page No. ensures that required communication and information between departments and functions is defined in documented procedures.3.3. coordination and control of activities for continual improvement (QS11) is the responsibility of the Management Representative and the Quality Team. forms and/or documents. Continual improvement activities include . In monthly meetings with the production staff. During Management Reviews.but are not be limited to . 1.: 22 of 46 Revision: D Issued: 2010/April/9
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1.2 Customer Communication In order to meet customer requirements and to ensure the proper and effective communication between the various departments within OPTEK and the customer.the following: • activities of the Quality Team under the responsibility of the Management Representative • actions on results from analysis of data (QS04) • evaluation of suppliers (PU04) • achievement of departmental quality objectives • results from internal quality audits • quality improvement proposals (QIP) • corrective actions and preventive actions (CAR) • periodic review of controlled documents (QS01) The objectives of the corporate Quality Policy are taken into consideration for planning of improvement. Manufacturing process improvement It is the responsibility of personnel in Manufacturing to continually monitor the performance of manufacturing processes regarding conformity with product characteristics and process parameters. is distributed to functions concerned and is attached to the main directory available at the front lobby. the effectiveness of continual improvement is reviewed and opportunities for improvement are identified. This list is updated as required. with the assistance of the Department Heads.2. memos. Sales establishes a list with some main contacts within OPTEK regarding customer inquiries.3 Communication 1. process performances of production areas are analyzed. and staff meetings. and opportunities for improvement are identified and implemented (QS11).
. 1. The Management Representative.

Audit activities are assigned to personnel not responsible for the area or activity to be audited. 1. It is the responsibility of Sales. in order to effectively communicate and interchange information with the customers.: 23 of 46 Revision: D Issued: 2010/April/9
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Internal and external communication related to the planning of products and processes (EG01) is defined by Engineering and/or Sales and/or the quality planning team. management is informed of the results of audits and follow-up audits and takes additional corrective action. follow-up audits are conducted to ensure that corrective action was implemented and is effective.
. As appropriate. shipping schedules and shipping information. objectives and results.1 Internal Audit of the Quality Management System Following the established documented Process Map #002 Internal Quality Audits.2 Internal Audit Plans Internal audits cover the entire Quality Management System and its processes. Where applicable. It is the responsibility of Engineering. Audit results are recorded and corrective action is taken as required. and that it meets the requirements of OPTEK. with the assistance of the IS-department. Audits do also verify if the Quality Management System is effectively implemented and maintained. The Management Representative ensures that audit results are part of Management Review.4 Internal Auditing 1. such as nonconformities and customer complaints. with the assistance of the IS-department. as applicable. Internal audits are planned and scheduled in such a way that all applicable clauses of ISO/TS 16949 and other additional quality system requirements are audited regarding compliance with this implemented Quality Management System and ISO/TS 16949. The Management Representative selects the auditors and ensures that they have required experience and knowledge to perform auditing activities. to develop. Records of internal audits are maintained. the auditing frequency is increased as appropriate. the Management Representative is responsible for internal audits. Audits are scheduled on the basis of the importance of the activity to be audited. including planned actions. to install and use electronic communication and design systems (such as CAD) that are compatible with the customers’ systems. Due to special circumstances.4. 1. including all shifts of these processes.Page No. implement and maintain a computerized system (such as EDI) for the receipt of planning information of customer orders.4. and are scheduled according to a yearly auditing plan and schedule prepared by the Management Representative (QS08).

Corrective actions are appropriate to the importance and impact of the addressed nonconformity. inspection and test results of product in process and finished product are audited to verify conformity to specified requirements.5.: 24 of 46 Revision: D Issued: 2010/April/9
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1. a disciplined problem solving method as outlined in the work instruction QSW02. is used as appropriate. recurrence of the nonconformity is prevented. Following the established procedure for corrective action (QS10). Responsible personnel in Manufacturing take required corrective actions. Training needs are identified and training is provided as required (QS02).4.4. 1.4. corrective actions and their results are recorded. corrective action is evaluated and defined. and the effectiveness of corrective action taken is reviewed. It is the responsibility of the Department Heads to inform the Sales/Service department of all customer complaints (QS06) and related corrective actions. 1. As appropriate. physical product can be inspected and tested by the auditor to confirm the product’s conformance to requirements and proper functionality.1. product in inventory and product ready for shipping is audited regarding compliance with packaging and labeling requirements.5. A summary of audit results of the manufacturing processes is prepared and included in Management Reviews. nonconformities are identified.
. Incoming product.Page No.4 Manufacturing Process Audit In addition to the normal internal audits of the Quality Management System. or any other suitable method. and to establish required corrective action. Audits of manufacturing processes are performed at least once per year. It is the responsibility of the Department Heads to establish and maintain records of corrective actions and their results. root causes are determined.3 Internal Auditor Qualification It is the responsibility of the Management Representative to ensure that internal auditors of the Quality Management System have the necessary experience and qualification for performing internal quality audits (QS08).5 Product Audit During the auditing of process in Manufacturing and the Warehouse.1 Corrective Action It is the responsibility of the Management Representative to implement and maintain the documented procedure QS10 Corrective Action that defines a corporate approach for corrective action. 1.1 Problem Solving To determine the root cause of a problem or deficiency.5 Corrective & Preventive Action 1. the Management Representative coordinates with the Manufacturing department the auditing of all manufacturing processes. 1.

2 Preventive Action It is the responsibility of the Management Representative to implement and maintain the documented procedure (QS09) Preventive Action that defines a corporate approach for preventive action to prevent the occurrence of potential nonconformities.1. It is the responsibility of the Department Heads to establish and maintain records of preventive actions and their results.3 Corrective Action Impact As applicable.1.: 25 of 46 Revision: D Issued: 2010/April/9
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1. deficiencies or problems determine the root causes determine the necessary preventive action implement the action follow-up on status and results review the effectiveness of preventive action. update all related documents with preventive action taken
Department Heads analyze and evaluate data of statistics (QS04) and perform periodic reviews of procedures (QS01) in order to detect deficiencies and problems and to take preventive action as required.1. the Quality Team applies implemented corrective action to other similar processes or products in order to correct nonconformity.Page No. deficiencies or problems. 1.4 Rejected Product Test / Analysis Product returned from customers (QA08) is analyzed by Quality Assurance in order to initiate appropriate corrective action and to prevent recurrence (Process Map – Process Flow). the Quality Team applies error-proofing methods in the corrective action process to prevent recurrence of the problem.5. 1.5.5. The Management Representative ensures that relevant information on preventive action is on the agenda of management reviews. • • • • • • • The process of preventive action includes the following steps: identify potential nonconformities.
.2 Error-Proofing As appropriate. Any employee can suggest a preventive action to the responsible Department Head by initiating a CAR (QSW01).5. 1.

and other functions concerned are informed as appropriate. as well as other requirements identified during product development and quality planning (EG01). determined and documented by the responsible department. The Sales department or responsible Department Head also ensures that during set-up and maintenance of new customer files (217-0020-001). Once these requirements are determined.1 Determination of requirements related to product It is the responsibility of the Sales department to ensure that customer requirements related to product are identified and defined. 217-0011-001). the fit or function of a product. customer requirements are identified and documented. Optek has established an International Traffic in Arms Regulations (ITAR) compliance Manual (89-00015-179) that addresses legal and ethical compliance and more specifically. Customer-designated special characteristics It is the responsibility of Engineering. with focus on processes affecting safety. customer returns (217-0027-001) and shipping of products. to identify and determine requirements not specified by the customer but necessary for the proper and intended use of the product or service. order taking and processing (217-0014-001. Symbols to be used for these special characteristics are those designated by the customer or other commonly used symbols used in the industry.
. and that these requirements are met as appropriate. they are used as input for product development and quality planning. compliance with regulatory requirements. the quality planning team and Manufacturing to apply.: 26 of 46 Revision: D Issued: 2010/April/9
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2 Realization Processes: 2. development and quality planning (EG01). represented by the Quality Planning Team. and understood by all functions concerned.1 Requirements Determination & Review 2. as well as customer needs and expectations are identified. including regulatory and statutory requirements Process Map #013 – Product Realization. In addition to customer requirements included in design. compliance with International Trade Regulations.1. Department Heads ensure that other requirements specified by customers. It is the responsibility of Engineering. or any other requirement of importance. Manufacturing prepares production schedules and material requirement reports to ensure availability of product for the fulfillment of customer orders. Based on sales forecast and/or other special requirements documented by the Sales department. document and control special characteristics designated by the customer. Potential new or modification to standard products will be reviewed per the New or Modified Standard Product Selection Procedure (99-00726-086) prior to the design and implementation into manufacturing.Page No.

2 Design and Development Planning The planning and control of design and development of product is the responsibility of Engineering (EG01). In the event of changes to product requirements.2. it is ensured that relevant documents and data are updated and that other functions concerned are notified. Manufacturing Feasibility The Sales department is responsible for the review of product specifications and customer requirements (Process Map # 003. Manufacturing feasibility is analyzed. Waiving the requirement for a formal review requires customer approval. or the acceptance or confirmation of an order (Process Map 012) from a customer. verification and validation of each design and development stage as appropriate. the originating department submits a Redfolder (217-0020-001) request to Engineering.2 Design & Development 2.2 Review of Requirements Related to Product. the project team determines the stages of the design and development project.Page No. or other changes to a quotation or order. and assigns responsibilities of required tasks and actions. the order or quotation is reviewed to ensure that • the product and customer requirements are clearly defined and documented • OPTEK has the capability to meet the requirements of the quotation or order • requirements of verbal orders are recorded and confirmed prior to acceptance • any differences between the customer’s order and OPTEK’s quotation are clarified and resolved.
. If there is a need for a design and /or development of a new standard product or for a change of the design or manufacturing process of a new standard product. The results of reviews and required actions are documented. defines the review. Process Map # 004. 217-0020-001) SDQA . Records of contract reviews are maintained. Prior to the submission of a quotation (Process Map #011)to the customer. 2.: 27 of 46 Revision: D Issued: 2010/April/9
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2.2.1 Design and Development If there is a need for the design and/or development of a new custom product or for a change of the design or manufacturing process of a custom product. During the planning process (Design Control Handbook). the New or Modified Standard Product Selection Procedure (99-00726-086) will be followed. and a risk analysis is performed. 2. confirmed and documented (217-0020-001).1.

Any past experience or information from similar projects is applied as appropriate. As applicable. manufacturing process design. FMEAs and applicable documents in order to ensure proper identification of special requirements of product and processes (EG01). product definitions. capability. Records of design input are maintained. and any other identified requirements. Input for product design and development includes functional and performance requirements. and the development and review of FMEAs and control plans.: 28 of 46 Revision: D Issued: 2010/April/9
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It is the responsibility of the Project Team Leader to ensure the effective communication and distribution of information between the team members and other functions participating in the planning process. Additional outputs for product design include FMEAs.4 Design and Development Input The originator of the Greenfolder (217-0010-001) identifies and documents the input requirements. 2. planning output is updated as appropriate. missing or conflicting information is clarified and resolved with the originator of the request before proceeding with the project.6 Design and Development Output The Project Team produces design output which is documented. 2. targets for productivity. including customer communication. other functions are consulted within their areas of expertise. Additional outputs for process design include drawings. which are reviewed by Engineering. as applicable (Design Control Handbook). and which are specified by the customer or by OPTEK. 2. meets design input requirements. FMEAs. As the planning process develops. cost. design reviews and other defined output results. product quality and performance objectives. design and development output provides data and information for product design.2.2.3 Multidisciplinary Approach Organizational and technical interfaces. is expressed in terms that can be verified and validated against design input requirements. statutory and regulatory requirements. Ambiguous. A multidisciplinary approach is also used for the development and monitoring of special characteristics. control
.5 Special Characteristics Special characteristics for product and processes. and customer requirements.Page No. special characteristics. are defined in the Project Plan and Schedule (Design Control Handbook) and are reviewed during each meeting of the team.2. Input for the development of manufacturing processes includes product design output data. 2. customer requirements.2. As required. contains or makes reference to acceptance criteria and includes critical and crucial characteristics for safety and functionality of the product or process. are identified and included in control plans.

Methods and guidelines specified by the customer are followed.2.8 Design and Development Verification The Project Team performs periodic design verifications to verify that design and development outputs meet the design and development input requirements.2. However. engineering change of production part. Processes. material suppliers and production process environment.9 Design and Development Validation The Project Team performs design validation to ensure that the designed product meets defined customer/user needs and requirements. If possible. lead time) are recorded at defined stages of the planning. 2.: 29 of 46 Revision: D Issued: 2010/April/9
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plans. 2. process performance and other information and data to ensure that manufacturing processes meet requirements (Design Control Handbook).2. Design outputs are reviewed prior to release. and are submitted to the Management Representative for input to management reviews.2. this validation should be performed prior to production. Monitoring The Project Team performs formal design reviews to identify any potential problems in meeting requirements and design goals. 2. it is understood that OPTEK is still responsible for the quality and performance of the prototype. Production part approval is requested for production parts.
. Problems are identified and appropriate action is taken. if required. Validation is according to customer requirements and includes program timing. OPTEK provides technical assistance and support to contractors/suppliers. Results of validations and necessary actions are recorded and maintained. As required. the product development includes the development of a control plan and a prototype (EG01).2.11 Product Approval Process Sample submission of production parts (QA10) for consequent customer approval is the responsibility of the Quality Assurance. 2. Records of design reviews and resulting actions are maintained. OPTEK is responsible for contracted materials and services. In the event that services for prototype development are outsourced. Progress and end results of design and development planning (such as effectiveness. partial validation is acceptable. equipment and materials used for the prototype should be the same as those used for final production runs. manufacturing location. Any change to these conditions requires customer notification and possible re-submission of production parts for approval. 2.10 Prototype Program If required by the customer. costs.Page No. Results of design verifications and resulting actions are recorded and maintained.7 Design and Development Review. Testing activities are monitored regarding timely completion and compliance with requirements.

3. Design Control Handbook). Purchasing &/or Supplier Development follows up on the suppliers’ progress
. the assistance of the Management Representative is requested. Results and necessary actions are documented and records are maintained.3.: 30 of 46 Revision: D Issued: 2010/April/9
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As appropriate. problems reported by the manufacturing involving supplied product.2.Page No.3 Supplier Quality Management System Development The Purchasing staff encourages suppliers to prepare for and/or implement the necessary procedures in order to meet the requirements of ISO 9001:2000 and to become certified.2 Regulatory Conformity Quality Assurance verifies that incoming purchased products and materials are in compliance with applicable regulatory requirements (QA02). Records of evaluation and selection of suppliers as well as related actions are maintained by Supplier Quality Engineering (SQE) and/or Supplier Quality Development (SQD). 2. Suppliers are evaluated and selected according to defined selection criteria and their ability to supply product that meets specified requirements. 2. All suppliers receive the manual TT Electronics/OPTEK Supplier Quality Requirements as an initial step for getting familiar with quality system requirements. the type of control applied to the supplier and the method used for verification of purchased product are identified and established by Engineering and/or Quality Assurance. As required. PU03). 2. Depending on the effect of the purchased product on the final product or production processes. are documented (217-0010-001. Supplier performance is monitored per the Supplier Quality Requirements paragraph 4 page 12 through the evaluation of product quality. The Quality Planning Team properly validates engineering changes. Production materials. delivery performance to acknowledged date and continual improvement. 2.1 Purchasing Process The Purchasing department is responsible for the effective and efficient operation of purchasing functions and activities (PU01. products and services are only purchased from approved suppliers (PU04). production part approval is extended for engineering approval of purchased products. Requests are reviewed and approved by Engineering. PU02.3. including proposed changes from suppliers.12 Control of Design and Development Changes Requests for design and development changes.3 Purchasing 2.

2. Verification at supplier’s site does not exclude subsequent rejection after receipt at OPTEK or OPTEK’s customer. the initial evaluation of the supplier. requirements for qualification of personnel. products or services are only purchased from the customer-designated supplier.3. The data describe and identify clearly the product to be ordered.3. cost competitiveness. As appropriate. Quality Assurance or Sales.
. material or service. these verification requirements and/or the method of product release are requested and defined by either Engineering. and Quality Management System requirements. and/or type and extent of inspection performed by the supplier. processes and equipment. as applicable. In the event that OPTEK or one of OPTEK’s customers wants to verify purchased product at the supplier’s premises. SQE and/or SQD ensures that required records are set up and maintained (PU02. Purchasing. Materials supplied by customer-designated suppliers are subject to receiving inspection by Quality Assurance (QA02). it is the responsibility of the Purchasing department to ensure that these materials. Verification activities at the supplier’s premises are coordinated through the Purchasing and/or Quality department. requirements for the approval of product.3. The adequacy of specified purchase requirements is ensured prior to submission to the supplier. 2.5 Purchasing Information For products and services purchased. problems reported by manufacturing involving supplied product. and/or the results of ongoing performance ratings of the supplier. PU03). Incoming purchased product is submitted to an incoming inspection (QA02) performed and recorded by Quality Assurance when supplier product is noncertified. procedures. including customer supplied product. the customer-approved supplier must be approved according to OPTEK’s approval criteria (PU04).7 Supplier Monitoring Supplier performance is monitored through evaluation of product quality. and are specified either in the purchase order and/or part specification. delivery performance.Page No. For the supply of materials for other applications. standards or other documents are referenced. The customer must approve alternate suppliers for this product. 2.6 Verification of Purchased Product and Incoming Product Quality The extent of quality control exercised over a supplier or over the supplied product is determined by Quality Assurance and depends on the importance of the product or product class (PU03). 2.3.4 Customer-Approved Sources Where according to customer contract.: 31 of 46 Revision: D Issued: 2010/April/9
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with the implementation of ISO 9001:2001 or an acceptable quality management system (Process Map: Supplier Development). continuous improvement efforts. statutory and regulatory requirements. and customer feedback. a product or material is to be purchased from a customer-designated supplier.

2 Work Environment 2. 2. These special conditions are included in the quality
. facility and equipment planning Plant. Records of supplier performance ratings are maintained.1.1 Plant.Page No.4.4.4. As applicable.1. Suppliers are informed of their rating and corrective action is taken as required. warehousing and transportation. develops contingency plans to meet customer requirements in the event of a production halt or labor shortage. others on request or at OPTEK’s discretion. this includes building facilities. Supplier Quality Requirements) of approved active suppliers and distributes on a regular basis to the top suppliers. monitored and evaluated considering • • • • • human factors operator and line balance availability of supplies use of automation work plans
Records of planning activities are maintained as per applicable master list of records.4. 2. New plans are developed as required. 2. facility and equipment planning of the effectiveness of existing equipment and facilities are the responsibility of Manufacturing and involves departments and functions concerned. necessary workspace and utilities as well as needed equipment and services such as maintenance. The productivity and effectiveness of existing operations is reviewed. Management ensures the timely availability of identified and approved resources. 2.4. Contingency plans are reviewed in the first quarter of each year regarding their validity. Engineering and Sales.4 Facilities & Equipment Management 2. with participation from Manufacturing.2 Contingency plans The Management Representative.2.1 Work Environment The quality planning team defines special conditions of the work environment that are necessary for the processes to meet defined requirements of product quality and regulatory requirements (EG01).1 Infrastructure The required infrastructure and resources for manufacturing activities are identified during quality planning (EG01).: 32 of 46 Revision: D Issued: 2010/April/9
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Purchasing/Supplier Quality develops periodic performance ratings (PU04.

3 Cleanliness of Premises It is the responsibility of management to ensure that the premises of OPTEK are kept clean and in a good state of order.2 Customer Owned Production Tooling It is the responsibility of the Toolroom & Manufacturing to ensure that customer owned tooling and fixtures are clearly identified with a metal plate or permanent marking method showing the ownership of the equipment. 2.4. housekeeping procedures are developed and implemented by individual Department Heads.4. manufacturing plan.2 Personnel Safety to Achieve Product Quality It is the responsibility of the Department Heads to ensure the safety of employees and to minimize risk of injuries when performing their duties. 2. The responsible Department Head ensures that customer owned product is identified. Any loss.: 33 of 46 Revision: D Issued: 2010/April/9
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plan. It is the responsibility of the Department Head to implement these requirements. 2. Any issues or concerns regarding health and safety of processes are reported to the departmental representative. used. a visual inspection of products.4. stored. During periodic cycle counts conducted by designated personnel in Manufacturing or Warehousing. It is the responsibility of Manufacturing and Warehouse to ensure that production facilities and the warehouse are kept clean and in good order.1 Customer Property Customer owned product supplied for production is inspected by Quality Assurance according to defined inspection requirements (QA02).3. including customer owned product.3. Accidents at the workplace are recorded (First Report of Injury & Supervisors Investigation Report) with copy to the HR Representative who keeps a master list of accidents for corrective or preventive actions. process sheet or other documents.2. damage or deterioration of customer-supplied product is recorded and the customer is notified.3 Customer Property 2.
. As required. is performed to verify the product’s condition and proper identification. Product safety is addressed during the design and development process under the responsibility of Engineering.4. 2. The HR Representative forms the Health and Safety Committee that includes representatives of applicable areas.2.4. handled and shipped in an appropriate manner in order to ensure its suitable condition for use.Page No.

by Quality Assurance and Toolroom.4. the Quality Assurance.4. and the required accuracy of these monitoring and measurement activities are defined during quality planning and specified in the manufacturing plan (EG01). QA01). calibrated and maintained (QA05). It is the responsibility of the applicable department to ensure that monitoring and measuring processes are capable for their intended purpose and are performed in a manner that is consistent with requirements. process traveler and/or inspection reports (QA02. and according to a recognized standard.4. • protected from damage and deterioration during handling. it is verified and confirmed that the software produces defined results. previous measuring results are reviewed regarding their validity (QA06). the basis applied for the calibration is documented. Toolroom and Engineering ensure that monitoring and measuring equipment and devices are controlled. The type of monitoring and measuring equipment/device/software to be used in Manufacturing. Manufacturing.2 Measurement System Analysis It is the responsibility of Quality Assurance to ensure that a Repeatability and Reproducibility study is conducted (QA07) for each measuring device referenced in control plans. • adjusted and re-adjusted as necessary to ensure required accuracy • identified with a unique identification number and the current calibration status. measuring equipment is • calibrated and/or checked in defined intervals or prior to use. where no recognized standard is used. • kept in a secure and restricted location to prevent misuse and improper adjustments that could invalidate calibration settings. Prior to the use of computer software for monitoring and measuring activities. if required (MF03. Corrective action on the measuring device or product affected is taken. including recall of nonconforming product. To ensure valid results. QA03.: 34 of 46 Revision: D Issued: 2010/April/9
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2. maintenance and storage In the event that monitoring and measuring devices are found out of calibration.4. QA04).4.Page No. Records of these verifications are maintained 2.4 Control of Monitoring & Measurement Devices 2. Records of these studies provide evidence of the variations present in the results of each type of measuring device and are taken into consideration when inspection reports are developed.1 Control of Monitoring and Measuring Devices To ensure accurate and reliable monitoring and inspection results.
.

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2.4.1 of ISO/TS 16949 are met.1 Control of Documents and Engineering Specifications Documents required by the Quality Management System are controlled documents. and which are either capable based on business history and/or previous services provided.1 Internal Laboratory It is the responsibility of Quality Assurance to define and document the scope of the capability of tests and inspection activities. These records include the identification of the equipment and the calibration standard. qualified laboratories are used for inspection.
. If a specific calibration service cannot be performed by an external laboratory.Page No. which can be performed by the inhouse laboratory facility of the Quality Assurance department.4 Laboratory Requirements
2.3.4.4. the impact on products previously measured with this equipment is reviewed and validated (QA06) and an Out-Of-Calibration Report is initiated as appropriate.5. test and calibration.6. 2.4. the review of related records 2.4. If suspect product/material has been shipped. and calibration results such as out-of-specification/conformity to specifications. 2. or in the absence of such a laboratory.4.4. When monitoring and inspection equipment is found out-of-specifications. the customers are informed and the product is recalled as required (QA06).3 Calibration / Verification Records The department performing the calibration of monitoring and measuring devices is responsible for the record keeping of calibration activities. or laboratories that are accredited to ISO/IEC 17025 or other equivalent national standard. revisions due to engineering changes.1 Document Control 2. as long as the requirements of clause 7. Only laboratories are used which include in their defined laboratory scope the required service to be performed.2 External Laboratory As required.5 Company Control Specifics 2. the original equipment manufacturer or their accredited representative can provide this service.1.5. and other contract services. Quality Assurance has specified and implemented technical requirements for the suitability of implemented procedures competency of personnel testing of product capability to perform these services correctly and according to pertinent process standards.4.

and that obsolete documents retained for any purpose are clearly identified. not to exceed two weeks. Based on the output from quality planning (EG01). readily available where needed. their approval for adequacy.5. Records of implementation dates in production are maintained. It is the responsibility of the applicable Department Head to ensure that current revisions of controlled documents are legible. by Engineering. Following the documented procedure EG02 Document and Data Control.5. it is the responsibility of the IS Department to establish a schedule for producing back-ups of defined computer data. #015. the Engineering Department is responsible for the identification. Schedules for backup responsibilities and compliance are documented. the equipment to be used. changes and re-approval.5.2. including documents and data of external origin such as standards and customer drawings. control and distribution of technical engineering documents. retrieval. are reviewed as soon as possible. These back-ups on tape or CD-ROM are kept in a secure place outside of the company’s premises. which defines the responsibilities for the development of controlled documents. are recorded. including changes. Incoming customer engineering standards and specifications.5. production processes. as well as the activities for
.1 Control of Production Manufacturing processes activities are performed under controlled conditions. Engineering documents developed by Engineering or engineering documents from the customer.Page No. identification and distribution.: 36 of 46 Revision: D Issued: 2010/April/9
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It is the responsibility of the Management Representative to implement and maintain the documented procedure (Process Maps #005. These documents or data describe in sufficient detail the product characteristics.1 Control and Retention of Records Records are maintained to provide evidence of activities and their results. #007. storage. that obsolete copies are replaced and destroyed or invalidated. Manufacturing and Document Control ensure that the necessary documents. 2.3 Control of Production Provision 2. document formats. revision status. data and operating instructions for the performance of manufacturing processes are developed and available to personnel. #006. protection. Department Heads are responsible for the proper identification. including the distribution of these documents. and are then distributed and implemented as required.2 Records Control 2. #016) Control of Documents. retention time and disposition of records according to the established documented procedure QS12. As required. 2.3. of conformance to requirements and of the effective operation of the Quality Management System.

Page No. Control plans are available for all production stages of products or parts. 2. and that activities for the monitoring and measurement of production processes are implemented and followed. as appropriate. manufacturing processes. are available at the workstation. These documents are made accessible to personnel at the work place. inspection activities.4 Verification of job set-ups Manufacturing is responsible for proper set-ups of production equipment. verification results and SPC records are recorded. 2. customer approval is obtained for the change. Quality Assurance performs a last-off comparison.5. control plans are updated by the quality planning team (EG01).3. logistics. As applicable. such as the quality plan or control plan. including instructions for special processes. Included are procedures for release.3. pre-launch and production processes.5. including assembly. as applicable. that production activities. control plans specify • the required controls for manufacturing processes • the methods used for monitoring applied controls over special characteristics (customer/OPTEK) • customer-required information • the reaction plan to be initiated when the process becomes unstable or not capable With changes of product specifications.5.2 Control Plan Control plans are developed during quality planning (EG01) and define the development of prototypes.3. The Manufacturing department ensures that operating instructions. delivery and post-delivery activities. It is also the responsibility of the Manufacturing department to ensure that the work environment is appropriate for the work being performed and meets statutory requirements. The HR Representative is responsible for compliance with regulatory requirements (MF09). Pre-Launch control plans heed the outputs of DFMEAs and PFMEAs. Work instructions and operating instructions are derived from the output data from quality planning. If required. supply sources or FMEAs. In case of set-up difficulties.: 37 of 46 Revision: D Issued: 2010/April/9
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monitoring and measuring of these processes. 2.3 Work Instructions It is the responsibility of the Department Heads to develop and maintain documented work instructions and operating instructions that are necessary for the performance of processes and activities affecting quality of products.
. or any changes affecting the product.

Page No. The status or availability of tooling and fixtures is clearly identified (TR03). repair (TR03. Toolroom and Quality Assurance are responsible for the design.3. • The Toolroom is responsible for the construction of tooling and fixtures (TR01). The set-up of tooling and equipment is the responsibility of Manufacturing (MF07).5 Preventive and Predictive Maintenance A master list of machinery and equipment that requires preventive maintenance to ensure continuous process capability is developed and maintained by Manufacturing. a tracking and follow-up system is put in place by Engineering or Manufacturing. Equipment and tooling and gauging that are kept in Manufacturing are packaged and preserved according to manufacturer’s guidelines and recommendations. review and approval of production tooling and fixtures. maintenance methods and inventory of replacement parts.3. As required. The actual maintenance status of each piece of equipment is identified.5. Tool modification and revision to documentation are coordinated between Engineering and the Toolroom. The Mexico Toolroom is responsible for preventive maintenance (TR03).5. These objectives are evaluated at least yearly regarding their achievement and opportunities for improvement. Engineering. construction. the Quality Planning Team is involved in the planning of changes to tooling and fixtures. 2. The Engineering department is responsible for design changes of tooling and fixtures.inventory system of frequently used replacement parts and a predictive maintenance analysis that assists in the review of preventive maintenance cycles. Manufacturing establishes programs for changes of perishable tools in production. Designated staff in Manufacturing performs required preventive maintenance. As required.6 Management of Production Tooling As applicable. storage and recovery (TR03) of production tooling. TR04).: 38 of 46 Revision: D Issued: 2010/April/9
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First-Offs are approved by Quality Assurance. The maintenance system includes a MIN/MAX . including a full dimensional inspection of the tooling and the monitoring of timely completion. statistical verification methods are used. As applicable.
• • • • • • •
In the event that design or construction is contracted to outside sources (EG04).
. the departments of Manufacturing. Established controls are followed to effectively coordinate all activities. Preventive maintenance objectives are established and documented in the first quarter of each year. these changes are passed on to the Toolroom for implementation. including engineering change level. 2.

where deficiencies become apparent when the product is already in use. product and material during production.5. 2.5 Identification of Traceability Identification and traceability Designated personnel in Quality Assurance. sensors manufactured by OPTEK are traceable by date codes. Corrective or preventive action is taken as required.5. Using the implemented computerized system in Manufacturing. QA03.8 Feedback of Information Based on customer feedback provided by Sales.3.
.Page No. Manufacturing and Warehouse identify incoming product and material. The production scheduling of custom-made parts is forecasted. Toolroom and Quality Assurance.: 39 of 46 Revision: D Issued: 2010/April/9
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Customer-supplied tooling is inspected and approved by Manufacturing. required records. approval of equipment and qualified personnel. regarding their ability to achieve planned results.5. including . 2.4 Validation of Processes Validation of processes for production Where the resulting process output cannot be verified through monitoring or measurement.5. WH02). Sales. Manufacturing and Quality Assurance.as applicable: criteria for review and approval. the Management Representative issues quarterly statistics (QS04) which are analyzed by the heads of Engineering. and product and material in storage with the product identification and inspection status (MF06. The quality planning team establishes procedures for the review. Quarterly. QA04. the Quality Planning Team validates production processes with the assistance of Manufacturing and Engineering. and re-validation in case that expected results are not achieved. the inventory turnover rate is calculated and corrective action is taken in case that the turnover rate is below the established minimum. the use of methods and procedures. Attention is given to special processes where the results cannot be verified through measurement or testing. 2.7 Production Scheduling Manufacturing is responsible for production scheduling.3. 2. QA02. approval and requirements of these processes.

The MRP-system in Manufacturing is used to ensure optimized inventory turns over time.6.5. When processing shipping orders (217-0014-001). The inventory turnover rate is periodically reviewed and corrective action is taken in the event that the turnover rate is below the established minimum. handling. Results are documented and include instructions for production processes.1 Monitoring and Measurement of Processes During Quality Management System Planning.5.7. packaging. As required. the processes of the Quality Management System are analyzed by the Management Representative and responsible Department Heads regarding their effectiveness.7 Monitoring & Measuring of Processes
2. Temperature sensitive products and materials are stored in the temperaturecontrolled room.1 Preservation of Product It is the responsibility of Manufacturing and the Warehouse to ensure the proper identification. 2.7. Manufacturing is responsible for keeping established inventory levels of finished product. minimum inventory levels and appropriate stock rotation (FIFO) of product and raw materials.2 Monitoring and Measurement of Manufacturing Processes To verify process capability and provide additional input for process control.5.6. reliability. corrective action is implemented to achieve planned results and product conformity. the condition of materials and products in the warehouse is verified to ensure that any deterioration or damage is detected and recorded. and that required corrective action is taken. and based on statistics of operational performance (QS04) and the achievement of quality objectives.Page No. the quality planning team arranges for the monitoring of new and modified manufacturing processes (EG01). using the computerized production scheduling system. handling and storage. This includes constituent parts of a product.2 Storage and Inventory During periodic cycle counts. verification and maintenance as well as objectives for manufacturing process capability. storage and protection of product and materials during receiving. to correct nonconformities or to improve the operational effectiveness and efficiency of the processes of the Quality Management System.5.
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Preservation
2. the staff in Warehousing ensures that FIFO is applied. shipping and production. maintainability and availability.5.6
2. 2.5. 2.

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Manufacturing ensures that processes are implemented according to control plans and other applicable procedures or documents in order to ensure that process capability and process performance is maintained according to customer part approval process requirements. In the event that purchased product is released for urgent production prior to inspection and acceptance by Quality Assurance.and where applicable by the customer.Page No. Corrective action is taken as per established procedure QS10 in order to restore required process capability and product quality. including adherence to specified measurement techniques. such as down times are recorded. If identified characteristics on the control plan become unstable or non-capable. unless otherwise approved by an authorized function . these reaction plans include containment of produced parts or products and 100% inspection.
. 2.5. In case of nonconformity of processes. If appropriate.5. in-process inspection (QA03) and final inspection (QA04) of product and materials. acceptance criteria and reaction plans. defined reaction plans are followed. sampling plans. It is the responsibility of Manufacturing to monitor process capability and to ensure that process capability and performance is according to applicable control plans. Effective dates of process changes are documented by Manufacturing. If required.8 Monitoring & Measuring of Product 2.1 Monitoring and Measurement of Product It is the responsibility of Quality Assurance to establish and maintain procedures and inspection reports for receiving inspection (QA02). Control plans and process flow diagrams are implemented. The warehouse staff performs a visual inspection of outgoing product to ensure that the product and packaging is in good condition and that marking and labeling requirements are met. Important events that are occurring during production.8. the product is recorded and controlled in order to permit recall and replacement in case of nonconformity of the product. the applicable reaction plan is followed. these corrective action plans are reviewed with and approved by the customer. Product is not released until all specified requirements have been met.

5. These inspection records document acceptance criteria. Quality Assurance selects accredited laboratories for certain inspection or testing activities. Records of these inspection results are verified.8. Qualified personnel in Manufacturing process rework Orders. or as otherwise specified by the customer. the customer is notified by Sales of the proposed use or repair of nonconforming product. Manufacturing ensures that the required concession is received prior to initiation of the repair. inspection results. The nonconformity of the product is verified and confirmed by Quality Assurance and verification results and recommended disposition or action are recorded. Quality Assurance performs a dimensional inspection and functional verification (QA12) for each product specified in control plans. Reworked product is re-inspected by Quality Assurance. Inspection results are recorded and records are maintained.9 Control of Nonconforming Product 2. Functions concerned are notified. 2. Manufacturing ensures that
.1 Control of Nonconforming Product and Reworked Product Nonconforming product and product without proper identification is quarantined and controlled according to the documented procedure QA01. reviewed and maintained.: 42 of 46 Revision: D Issued: 2010/April/9
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Product that does not meet specified requirements is rejected and quarantined per established documented procedure. Manufacturing. 2. according to the following options: • rework to meet specified requirements • accept with or without repair by concession • re-grade for alternative applications • reject or scrap If the acceptance with or without repair requires the concession of the customer or the approval or permit of a regulatory body or other authority. Where applicable. As required. Quality Assurance. Detailed instructions for required rework are available to operators in work instructions. whether the product was accepted or rejected and the inspection authority responsible for the product release.5.Page No.9. As appropriate and required.2 Dimensional Inspection and Functional Testing At least once every twelve months. Engineering or Sales review and authorizes the release of quarantined product for its final disposition. Results are available to the customer upon request.5.

including the type of nonconformity. or manufacturing processes are different from the product or process approved by the customer.
. As required. the Engineering department with Manufacturing & Quality Assurance and Sales department analyze the impact of the nonconformity and take appropriate action.: 43 of 46 Revision: D Issued: 2010/April/9
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the reworked product is identified with the actual condition of the product. including the customer’s release authorization. the customer is informed and the nonconforming product is recalled. or after its use in production or service. Manufacturing keeps records of expiration dates and quantities of authorized deviations and ensures that normal production activities are re-instated after expiration of engineering deviations. actions taken and concessions obtained are maintained in First Time Quality reports.2 Customer Waiver In the event that manufactured product.9. As required.Page No. 2. In the event that nonconforming product is detected after the product was shipped to the customer. the request for temporary change or deviation is submitted to Engineering for approval (EG01). Nonconforming purchased product and material is returned to the supplier with a Supplier Corrective Action Request (Process Map: SCAR Process) issued by Supplier Quality Assurance (QA11).5. or purchased product. or that temporary change to product and processes is required. customer production part approval is obtained (QA10). Records of nonconforming product. Products manufactured and shipped on customer authorization are identified as such on each packaging unit or container.